Sirna Therapeutics Granted Broad Patent Covering siRNAs Targeting Huntington's Disease
04 10월 2005 - 9:43PM
PR Newswire (US)
Patent Strengthens Sirna's On-Going Drug Discovery and Development
Efforts SAN FRANCISCO, Oct. 4 /PRNewswire-FirstCall/ -- Sirna
Therapeutics, Inc. (NASDAQ:RNAI) the leading clinical-stage RNAi
therapeutics company, announced today that the Australian Patent
Office has issued a broad patent covering vector expressed siRNAs
targeting the Huntington's disease (HD) gene. This is the first
patent issued anywhere in the world which encompasses 'vector
expressed' siRNAs targeting a disease gene. The patent claims,
which are not limited to a specific siRNA sequence or structure,
broadly cover any vector expressed siRNA used against the HD gene.
This patent significantly advances Sirna's position as the leader
in the development of RNAi-based therapeutics for the treatment of
Huntington's disease. Entitled "siRNA-mediated gene silencing with
viral vectors" (AU 2005200828), the patent further strengthens
Sirna's portfolio and the Company's leadership position in
developing siRNA-based therapeutics. This patent includes vector
expressed siRNAs with 3' -overhangs and blunt ends and short
hairpin RNA (shRNA). The patent also covers methods of using siRNAs
to inhibit Huntington's disease gene expression. To date, Sirna has
filed over 125 patents in multiple countries around the world on
the use of siRNAs targeting mammalian genes and viruses responsible
for human diseases. Bharat M. Chowrira, PhD, JD, Vice President
Legal Affairs and Chief Patent Counsel of Sirna Therapeutics,
stated, "Securing the broad siRNA patent for the HD gene enables
Sirna to expand its dominant patent portfolio, while demonstrating
the Company's commitment to developing RNAi-based therapeutics for
diseases that, until now, have proven difficult to treat by
conventional means. In addition to demonstrating the strength of
our science, today's announcement advances our strategy of
obtaining broad coverage of siRNAs targeting an entire gene. It is
likely that Sirna's broad siRNA claims covering an entire targeted
gene, such as the HD patent, will issue worldwide, and thus prevent
other companies from pursuing such targets." The issuance of
today's patent follows three target patents and two broad- based
siRNA patents secured this year by Sirna in the United Kingdom. The
UK patents, which address the Hepatitis C Virus, Vascular
Endothelial Growth Factor and Vascular Endothelial Growth Factor
Receptor-1, broadly cover siRNAs against these targets. The company
was also issued broad patents covering the chemical and structural
modifications of siRNAs necessary for the creation of viable
siRNA-based therapeutics as well as siRNAs targeting conserved
regions of viruses and mammalian genes. In the coming months Sirna
expects that patents with similar scope and breadth will be issued
in other major countries including the U.S., Europe and Japan. The
HD patent, which is exclusively licensed to Sirna, is based on
pioneering research carried out by Dr. Beverly Davidson, Ph.D., Roy
J. Carver Professor in Internal Medicine Professor, Neurology and
Physiology & Biophysics Vice Chair for Research, Dept of
Internal Medicine Associate Director, Center for Gene Therapy
University of Iowa College of Medicine. Dr. Davidson is a member of
the Sirna Scientific Advisory Board and a collaborator on Sirna's
efforts in HD. In 2004, Sirna partnered with Dr. Davidson and
Targeted Genetics, Corp. (NASDAQ:TGEN) to move forward a novel
treatment for HD capitalizing on the cutting-edge work of Dr.
Davidson, the novel adeno-associated viral vector (AAV) delivery
technology of Targeted Genetics and Sirna's siRNA constructs. In
addition, Sirna and Targeted Genetics have sponsored a joint
research collaboration with Krys Bankiewicz, M.D., Ph.D., Professor
of Neurological Surgery, University of California, San Francisco.
Dr. Bankiewicz is developing a unique delivery mechanism to
introduce AAV vector encoded siRNA constructs directly into the
brain to target the HD gene. About Huntington's disease
Huntington's Disease (HD) is a devastating, inherited, degenerative
brain disorder that is progressive and always fatal and for which
there is, at present, no effective treatment or cure. HD affects
more than 30,000 people in the United States, with another 200,000
at risk of inheriting the deadly gene. The disease-causing gene
produces a protein that is toxic to certain brain cells, and the
subsequent neuronal damage leads to the movement disorders,
psychiatric disturbances and cognitive decline that characterize
this disease. It is a dominant, fatal neurological disorder with no
cure and no treatment that directly reduces mutant htt gene
expression or otherwise prevents onset of the disease. Early in
2005, Sirna announced its selection of investigational compounds
for preclinical development based on the groundbreaking work of the
Company's research collaborator, Dr. Beverly Davidson at the
University of Iowa. The Patent Portfolio Sirna has both in-licensed
patents with third parties and filed patents on technology
discovered inside the Company. Sirna's internal scientific work has
resulted in 44 issued patents and over 250 pending patents. These
patents include: 10 pending patents for siRNAs & micro-RNAs,
one granted and 10 pending patents for "No-Ribo" siNAs, 5 pending
patents for Multifunctional siRNAs, 23 issued and over 70 filed
patents for Oligonucleotide Chemistry and Delivery, 15 issued and
25 filed patents for Oligonucleotide Manufacturing, and three
granted and over 100 patents pending for fully enabled siRNAs
against specific gene targets. To ensure that Sirna can bring
RNAi-based therapeutics to the market, the company has pursued an
in-licensing strategy to provide itself total freedom to do so in
all disease areas. Sirna's in-licensing strategy has encompassed
several key patents, including the Tuschl Patent from the
University of Massachusetts which covers the seminal RNA
interference technology covering siRNA for uses relating to human
and veterinary therapeutic, prophylactic, diagnostic and healthcare
applications, as well as, Carnegie Patent from the Carnegie
Institution of Washington and UMASS. The Carnegie Patent is based
on the pioneering work of Drs. Andrew Fire and Craig Mello in C.
elegans governing genetic inhibition of genes by double-stranded
RNA via RNAi. Sirna's Enabling Target Patents Sirna has filed
enabling patents for over 125 important mammalian disease targets
including: alpha-synuclein (Parkinson's disease), HBV (hepatitis
B), HCV (hepatitis C), HD (Huntington's disease), HIV (human
immunodeficiency virus), HR (hairless gene), IL-4, IL-13, IL-4
Receptors, IL-13 Receptors (asthma, respiratory diseases), NOGO
& NOGO Receptors (spinal cord injury), PTP-1B (diabetes,
obesity), RSV (Respiratory Syncytial virus), and VEGF
(angiogenesis, AMD, diabetic retinopathy, cancer, kidney disease).
About Sirna Therapeutics Sirna Therapeutics is a clinical-stage
biotechnology company developing RNAi-based therapies for serious
diseases and conditions, including age-related macular degeneration
(AMD), hepatitis B and C, dermatology, asthma, Huntington's
Disease, diabetes and oncology. Sirna Therapeutics has presented
interim Phase 1 clinical trial data for its most advanced compound,
Sirna-027, a chemically optimized siRNA targeting the clinically
validated vascular endothelial growth factor pathway to treat AMD.
The results to date, demonstrate that Sirna-027 for AMD is safe and
well tolerated. Visual acuity has stabilized in 100 percent of
patients treated and clinically significant improvement, of three
lines or greater on the ETDRS eye chart, has been observed in 25
percent of the patients tested. Sirna Therapeutics has
collaborations with Eli Lilly and Company, Targeted Genetics,
Archemix Corporation and Protiva Biotherapeutics. Sirna has a
leading intellectual property portfolio in RNAi with 43 issued
patents and over 250 pending applications worldwide. More
information on Sirna Therapeutics is available on the Company's web
site at http://www.sirna.com/. Safe Harbor Statement Statements in
this press release which are not strictly historical are
"forward-looking" statements which should be considered as subject
to many risks and uncertainties. For example, there is a
significant risk for any given patent application that it will not
become an issued patent, or that for any issued patent, it could be
subject to challenge or may not be enforceable. Further, Sirna's
ability to develop products and operate as a going concern is
contingent upon having readily available cash to fund its operating
programs and is subject to the escalating expenses and risks
associated with the initiation of clinical trials and their
potential outcomes. Additional risks and uncertainties include
Sirna's early stage of development and short operating history,
Sirna's history and expectation of losses and need to raise
capital, Sirna's need to obtain clinical validation and regulatory
approval for products, Sirna's need to obtain and protect
intellectual property, risk of third-party patent infringement
claims, Sirna's need to attract and retain qualified personnel,
Sirna's need to engage collaborators, availability of materials for
product manufacturing, the highly competitive nature of the
pharmaceutical market, the limited trading volume and history of
volatility of Sirna's common stock, Sirna's concentration of stock
ownership, and risks from relocating Sirna headquarters. These and
additional risk factors are identified in Sirna's Securities and
Exchange Commission filings, including the Forms 10-K and 10-Q and
in other SEC filings. Sirna undertakes no obligation to revise or
update any forward- looking statements in order to reflect events
or circumstances that may arise after the date of this release.
Contacts: Rebecca Galler Robison, Senior Director, Corporate
Strategy Sirna Therapeutics, Inc., +1-303-449-6500 Francesca
DeMartino (investors) or Jason Rando (media), both of The Ruth
Group, +1-646-536-7024 / 7025 DATASOURCE: Sirna Therapeutics, Inc.
CONTACT: Rebecca Galler Robison, Senior Director, Corporate
Strategy Sirna Therapeutics, Inc., +1-303-449-6500; or Investors,
Francesca DeMartino, +1-646-536-7024, or Media, Jason Rando,
+1-646-536-7025, both of The Ruth Group, for Sirna Therapeutics,
Inc. Web site: http://www.sirna.com/
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